Identity
- Trade Name
- Surestep EUDAMED
- Device Name
- SureStep Big Shot AFO EUDAMED
- Model / Reference
- 1907-BIG-SS-2280 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810080701069 EUDAMED
- Basic UDI-DI
- 00810080701907-BIG-SSG7 EUDAMED
- Direct Marketing DI
- 00810080701069 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Ankle/foot orthosis
Surestep by Surestep, LLC — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 00810080701907-BIG-SSG7 | Class I | Active |
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Manufacturer
- Manufacturer
- Surestep, LLC
- EUDAMED SRN
- US-MF-000003047
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 348f499a-b0cb-402a-9ec1-0c54ec363380 61 fields · synced Jun 18, 2026